In Genentech’s ongoing efforts to transparently communicate with the hemophilia community, we are sharing two updates to the Hemlibra label that were requested by the FDA. These changes, which were accepted and implemented on March 10, 2021, impact the Warnings and Precautions (sections 5.1 and 5.2) and Clinical Pharmacology (section 12.3) sections of the label. Importantly, the overall benefit/risk profile of Hemlibra remains positive.
First, the Warnings and Precautions sections have been updated to remind healthcare providers to consider the long half-life of Hemlibra when prescribing aPCC after Hemlibra has been discontinued. Hemlibra has a half-life of 26.9 days. Assuming it takes 5-6 half-lives to clear a medicine from the body, Hemlibra may remain present in the body for up to 6 months after the final dose. Therefore, due to the long half-life of Hemlibra, the potential for interaction with aPCC may persist for up to 6 months after the last dose.
Separately, the FDA requested that the Specific Populations section of the label be updated to make clear to healthcare professionals that Hemlibra has not been studied in people with severe hepatic or renal impairment and congenital hemophilia A with and without factor VIII inhibitors.
Genentech is in regular communications with the FDA, and it is not unusual for the agency to ask manufacturers to update medicine labels to clarify information. We remain committed to delivering safe and effective medicines of the highest quality to the patients we serve and will continue to keep this community informed of any further updates.
Sr. Manager, Patient Advocacy Relations - OMNI